Cleared Traditional

K820811 - PROXIMATE DISPOSABLE SKIN STAPLERS

K820811 is the FDA 510(k) clearance for PROXIMATE DISPOSABLE SKIN STAPLERS by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAG) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K820811 · Ethicon, Inc. · General & Plastic Surgery device
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Aug 1982
Decision
150d
Days
Class 2
Risk

K820811 is an FDA 510(k) clearance for the PROXIMATE DISPOSABLE SKIN STAPLERS. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 150 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K820811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date August 20, 1982
Days to Decision 150 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 115d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAG Stapler, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4740
Definition A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAG Stapler, Surgical

All 29
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K820811.
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
K844417 · Davis & Geck, Inc. · Dec 1984
APPOSE ULE STERILE DISPOS. SKIN STAP
K840177 · Davis & Geck, Inc. · Mar 1984
APPOSE DISPOS. SKIN STAPLER W/AUTO
K840178 · Davis & Geck, Inc. · Mar 1984
DEKNATEL SKIN STAPLE EXTRACTOR
K821228 · Howmedica Corp. · May 1982
APPOSE SKIN STAPLER
K811030 · Davis & Geck, Inc. · May 1981
PROXIMATE*II DISPOSABLE SKIN STAPLER
K803038 · Ethicon, Inc. · Dec 1980